FDA 510(k) Application Details - K123097

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K123097
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	PAUL BIGGINS Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2012
Decision Date	02/13/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review